FDA Regulatory Affairs - 9781420073546

CRC Press

FDA Regulatory AffairsA Guide for Prescription Drugs, Medical Devices, and Biologics\nAuthor(s): Douglas J. Pisano, David S. Mantus\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: CRC Press Inc\nISBN-13: 9781420073546, 978-1420073546\nSynopsis\nExamines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.\n\nFDA Regulatory Affairs:\n\nprovides a blueprint to the FDA and drug, biologic, and medical device development\noffers current, real-time informatiok